AR-6300, AR-6400 Hematology Analyzer User Manual

Auto Hematology Analyzer
AR- 6300
AR- 6400
Operation Manual
For In Vitro Diagnostic Use
About this manual
Release Date: March 9, 2020
Item No.: P01.91.300254-04
Statement
This manual will help you understand the operation and maintenance
of the product better. It is reminded that the product shall be used
strictly complying with this manual. User’s operation failing to comply
with this manual may result in malfunction or accident for which the
manufacturer cannot be held liable.
The manufacturer owns the copyrights of this manual. Without prior

written consent of the manufacturer, any materials contained in this
manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to

confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose
such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him,
expressly or implicitly, any right or license to use any of the intellectual
properties of the manufacturer.
The manufacturer reserves the right to modify and update this manual
without prior notice.
The manufacturer reserves the final explanation right to this manual.
Warning
This system can only be operated by test professionals, doctors, lab

workers or personnel for system maintenance and troubleshooting,
who have been trained by the manufacturer.
It is important for the hospital or organization that employs this

equipment to carry out a reasonable maintenance schedule. Neglect of
this may result in machine breakdown or injury of human health.
Make sure to use the instrument under the provisions of this Operation
Manual. Otherwise, the instrument may not work normally, the test
result is unreliable and it may damage the instrument parts and
endanger people’s safety.
Avoidance from potential hazard
User should read the Safety Notice and Operation Notice carefully.
There are several safety warning signs in this manual to help operators
avoid hurting themselves or making the instrument damaged, resulting
in incorrect measuring results:
Warning: The instrument must be operated as the operating

procedures, or else, there will be great hazards to both operator and
environment.
Caution: Emphasize the operating methods that must be obeyed.

Avoid potential hazard or making the instrument damaged, resulting in
incorrect measuring results.
Notice: To emphasize important information. All personnel that may

operate, maintain, remove, service the instrument should read this
manual carefully.
Safety Notice
To operate the instrument safely and effectively, be sure to read the

following notices first. Operating the instrument, without following the
appointed methods of the manufacturer, may break down the
defensive function of the system, and cause bodily injury or damage
the instrument.
Avoid electric shock
1) When the power is on, the unauthorized maintenance personnel

should not open the instrument.
2) If liquid enters into the instrument or the instrument has leakage,
please shutoff the power immediately, and contact the Customer
Service Department of the manufacturer or your local distributor in due
course. Improper use of the liquid may cause electric shock and result
in damaging the instrument.
Defense for biohazard and chemical hazards
Improper use of the sample may result in being infected.
Avoid hand touch the sample, reagent and waste directly. When
operate the instrument, be sure to wear gloves to avoid being infected.
If the skin touched the sample, manage it according to operator

working standard or inquiring a doctor to take remedial measures
immediately.
Use the reagent carefully to avoid hand and clothes touch directly.
Once hand or clothes touch, flush the touched area with soap and
plenty of water immediately.
If the reagent enters into the eyes incautiously, flush with plenty of
water at once, and inquire a doctor for further treatment.
Be sure not to use flammable dangerous materials around the

instrument.
Reagents, quality control serum, some materials in the sample are
controlled by Pollution Regulations and Standard for Discharge of
Pollutants. Please abide by the local discharge regulation and inquire
related reagent manufacturer.
Prevention of fire and explosion
Operation Notice
To operate the instrument safely and reliably, be sure to obey the

following notices.
Purpose
Pay attention to the application range of the instrument. Make sure

your use does not exceed the application range.
Limitation of operating environment
The instrument should be installed according to the required

installation environment of the manual. Installation and use out of the
appointed range may cause unreliable results, and make the
instrument damaged. Contact the Customer Service Department of the
manufacturer or your local distributor if you need to change the state of
the instrument.
Limit of operator
Only personnel trained and authorized by the manufacturer can

operate the instrument.
Maintenance and service
Be sure to service and maintain the instrument according to this

manual strictly.
Table of Contents
Table of Contents
Table of Contents ................................................................................. i
Chapter 1 Instrument Introduction ................................................... 1
1.1 Composition ................................................................................ 1
1.1.1 Host ...................................................................................... 1
1.1.2 Accessory ............................................................................. 1
1.2 Purpose ....................................................................................... 2
1.3 Specifications .............................................................................. 4
1.4 Structure .................................................................................... 11
1.4.1 Front Panel ......................................................................... 11
1.4.2 Rear Panel ......................................................................... 12
1.5 Operation .................................................................................. 13
1.5.1 Display Screen ................................................................... 13
1.5.2 Menu................................................................................... 14
1.5.3 Version Information ............................................................ 18
1.6 Detection Principle .................................................................... 19
i
Table of Contents
1.6.1 Detection Principles of WBC, RBC and PLT ...................... 19
1.6.2 Detection Principle of HGB ................................................ 21
1.6.3 Volume Distribution of Blood Cell ....................................... 21
1.6.4 Results and Calculation of Parameter Measurement ........ 22
Chapter 2 Installation ....................................................................... 25
2.1 Package .................................................................................... 25
2.2 Unpack ...................................................................................... 25
2.3 Installation Requirements .......................................................... 26
2.4 Reagent Tubing Connection ..................................................... 28
2.4.1 Lyse Connection ................................................................. 28
2.4.2 Diluent Connection ............................................................. 28
2.4.3 Waste Connection .............................................................. 28
2.5 Recorder Paper Installation....................................................... 30
2.6 Keyboard and Mouse Installation .............................................. 30
2.7 Printer Installation (Optional) .................................................... 31
2.8 Power Cable Connection .......................................................... 31
Chapter 3 Sample Analysis.............................................................. 32
3.1 Preparation before Startup ........................................................ 32
ii
Table of Contents
3.2 Startup ....................................................................................... 32
3.2.1 Function .............................................................................. 34
3.3 Background Test ....................................................................... 36
3.4 Quality Control .......................................................................... 39
3.5 Preparation for Sample Collection ............................................ 39
3.5.1 Venous Blood Collection .................................................... 39
3.5.2 Capillary Blood Collection .................................................. 39
3.5.3 Prepare Samples in Prediluted Mode ................................ 40
3.5.4 Prepare Samples in Capillary Mode ................................... 41
3.5.5 Sample Mixing .................................................................... 41
3.6 Sample Count and Analysis ...................................................... 42
3.6.1 Sample Information Input ................................................... 42
3.6.2 Procedures of Sample Count and Analysis ........................ 44
3.6.3 Parameter Alarm ................................................................ 44
3.6.4 Histogram Alarm ................................................................. 45
3.7 Analytical Results Modification .................................................. 46
3.8 Shutdown .................................................................................. 48
iii
Table of Contents
Chapter 4 Quality Control ................................................................ 50
4.1 Edit Quality Control Files .......................................................... 50
4.2 Quality Control Run ................................................................... 52
4.3 Quality Control Graph ............................................................... 54
4.4 Quality Control List .................................................................... 56
Chapter 5 Calibration ....................................................................... 58
5.1 Operator Calibration .................................................................. 59
5.1.1 Background Test ................................................................. 59
5.1.2 Assurance of Repeatability ................................................. 59
5.1.3 Calculate Calibration Factors ............................................. 61
5.1.4 Modify Calibration Factors ................................................. 61
5.2 Auto Calibration ......................................................................... 62
Chapter 6 Setting .............................................................................. 65
6.1 Date & Time .............................................................................. 65
6.2 Printout ...................................................................................... 66
6.3 Control ....................................................................................... 74
6.4 Limits ......................................................................................... 77
6.5 Department Information ............................................................ 79
iv
Table of Contents
6.5.1 Add record information ....................................................... 80
6.5.2 Print department information .............................................. 81
6.6 Operator Information ................................................................. 81
6.6.1 Add operator information .................................................... 83
6.6.2 Print operator information ................................................... 84
Chapter 7 Review .............................................................................. 85
7.1 Sample Review ......................................................................... 85
7.2 Detail Review ............................................................................ 89
Chapter 8 Service ............................................................................. 92
8.1 Flush ......................................................................................... 92
8.2 Enhanced Flush ........................................................................ 93
8.3 Cleaning .................................................................................... 93
8.4 Prime Chamber Outside............................................................ 93
8.5 Drain Chambers ........................................................................ 93
8.6 Drain All ..................................................................................... 93
8.7 Prime Diluent ............................................................................. 94
8.8 Prime Lyse ................................................................................ 94
v
Table of Contents
8.9 Prime ......................................................................................... 94
8.10 Maintenance............................................................................ 94
8.11 Mechanic ................................................................................. 94
8.12 Special ..................................................................................... 96
Chapter 9 Maintenance .................................................................... 97
9.1 Routine Maintenance ................................................................ 97
9.1.1 Clean the appearance ........................................................ 97
9.1.2 Replace fuse ...................................................................... 98
9.2 Daily Maintenance..................................................................... 98
9.3 Weekly Maintenance ................................................................. 99
9.4 Monthly Maintenance .............................................................. 100
9.4.1 Clean the dust of the instrument every month ................. 100
9.4.2 Clean the sample probe every month .............................. 100
9.4.3 Clean the shielded box every month ................................ 101
9.5 Yearly Maintenance ................................................................. 101
9.6 Maintenance before Transport or for the Instrument that will not
be used for a long time.................................................................. 101
Chapter 10 Troubleshooting .......................................................... 104
vi
Table of Contents
10.1 Abnormal Startup................................................................... 104
10.2 Waste Full ............................................................................. 104
10.3 Diluent Empty ........................................................................ 104
10.4 Lyse Empty............................................................................ 105
10.5 WBC Clog or RBC Clog ........................................................ 105
10.6 HGB Error ............................................................................. 106
10.7 HGB Bubbles ........................................................................ 106
10.8 Recorder out of Paper ........................................................... 106
10.9 Recorder too Hot ................................................................... 107
10.10 The Result of Background Test too high ............................. 107
Chapter 11 Help............................................................................... 109
Appendix 1 Symbol ........................................................................ 110
A 1.1 Symbols on the Instrument .................................................. 110
A 1.2 Product’s Outer Packaging Illustration ................................. 111
Appendix 2 Specification ............................................................... 113
A 2.1 Reagent ............................................................................... 113
A 2.2 Parameter Information ......................................................... 113
vii
Table of Contents
A 2.3 Sampling Characteristics ..................................................... 115
A 2.4 Performance Index............................................................... 115
A 2.5 Background Range .............................................................. 116
A 2.6 Linear Range ....................................................................... 117
A 2.7 Repeatability Index .............................................................. 117
A 2.8 Pollution Rate....................................................................... 118
A.2.9 Accuracy .............................................................................. 118
A 2.10 Input / Output ..................................................................... 119
viii
Instrument Introduction
Chapter 1 Instrument Introduction
1.1 Composition
Auto Hematology Analyzer consists of two parts: the host and the
accessories.
1.1.1 Host
Control the process of sample collection, dilution and analysis,
including the following units:
(1) Power supply unit
(2) Central control circuit unit
(3) Dilute unit
(4) Display unit
(5) Thermal recorder
1.1.2 Accessory
Including the following accessories:
(1) Mouse
(2) Printer (Optional)
1
(3) Touch pen (Optional)
(4) Power cable
(5) Ground cable
(6) Serial port cable
1.2 Purpose
This analyzer is used for detecting the parameters of RBC, WBC, HGB
and differential counting. The following 20 parameters and 3
histograms of blood can be obtained from the analysis.
Item Abbreviation Unit
White blood cell or leukocyte WBC 103/μL
Lymphocyte LYM# 103/μL
Mid-sized cell MID# 103/μL
Neutrophil NEUT# 103/μL
Lymphocyte percentage LYM% %
Mid-sized cell percentage MID% %
Neutrophil percentage NEUT% %
Red blood cell or erythrocyte RBC 106/μL
Hemoglobin concentration HGB g/dL
Hematocrit HCT %
2
Mean Corpuscular (erythrocyte)

MCV fL
Volume
Mean Cell Hemoglobin MCH pg
Mean Cell Hemoglobin Concentration MCHC g/dL
Red Blood Cell Distribution

RDW-SD fL
Width-Standard Deviation
Red Blood Cell (erythrocyte)

Distribution Width-Coefficient of RDW-CV %
Variation
Platelet PLT 103/μL
Mean Platelet Volume MPV fL
Platelet Distribution Width PDW %
Plateletcrit PCT %
Plateletcrit-Large Cell Ratio P-LCR %
WBC
White Blood Cell Histogram
Histogram
RBC
Red Blood Cell Histogram
Histogram
Platelet Histogram PLT Histogram
Table 1-1 Parameters
3
Name Abbreviation Provided
White Blood Cell Histogram WBC Histogram √
Red Blood Cell Histogram RBC Histogram √
Platelet Histogram PLT Histogram √
Table 1-2 Histograms
1.3 Specifications
Standard Classification of the Instrument
According to anti-electrical shock hazard: Grade II, Pollution 2
According to the defence for deleterious liquid: General Device
(Closing device of non-defensive liquid)
According to the recommended disinfection/sterilization method of the
manufactory: Disinfectant device recommended by manufactory
According to safety degree in condition that using gas mixture of
flammable anesthetic gas and air or gas mixture of oxygen and nitrous
oxide: Do not use the equipment in condition that using gas mixture of
flammable anesthetic gas and air or gas mixture of oxygen and nitrous
oxide.
According to the working status: Continuous running equipment
Principles of Measurement
Blood cells are counted and sized by Electrical Impedance Method.

Hemoglobin is determined by Colorimetric Method.
4
Parameters of Measurement
Basic Parameters:
White Blood Cell WBC 103/μL
Red Blood Cell RBC 106/μL
Hemoglobin concentration HGB g/dL
Platelet PLT 103/μL
Table 1-3
Derived from Histograms:

Lymphocyte percentage LYM% %
Mid-sized cell percentage MID% %
Neutrophil percentage NEUT% %
Mean Corpuscular
MCV fL
(erythrocyte) Volume
Red Blood Cell Distribution

RDW-SD fL
Width-Standard Deviation
Red Blood Cell (erythrocyte)

Distribution Width-Coefficient RDW-CV %
of Variation
Mean Platelet Volume MPV fL

Platelet Distribution Width PDW %
5
Plateletcrit-Large Cell Ratio P-LCR %
Table 1-4
Calculated Parameters:
Lymphocyte LYM# 103/μL
Mid-sized cell MID# 103/μL
Neutrophil NEUT# 103/μL
Hematocrit HCT %
Mean Cell Hemoglobin MCH pg
Mean Cell Hemoglobin

MCHC g/dL
Concentration
Plateletcrit PCT %
Table 1-5
Sampling Features:
Sample Volume:
Venous Blood Mode: 10μL Venous Blood
Capillary Blood Mode: 10μL Capillary Blood
Prediluted Mode: 20μL Capillary Blood
6
Venous and Capillary Blood Mode:
WBC/HGB 1:285
RBC/PLT 1:21667
WBC/HGB 1:500
RBC/PLT 1:43333
Cell Counting Aperture Size:
WBC: 100μm RBC/PLT: 70μm
Throughput: Up to 35 samples per hour
Working mode:
Double counting pathway + independent HGB detection system
Display:
Liquid Crystal Display (LCD), touch screen resolution: 800*600
Language: English, Spanish, Italian, French, Portuguese
Indicator: Power indicator light
Interface:
One power input socket
7
One RS232/C serial port
One VGA interface
Two USB interfaces
Recorder:
Rapid Thermal Recorder: Recording width: 35mm, Paper width: 80mm
Precision Specifications of the Instrument
Repeatability:
Parameter Repeatability
WBC ≤ 2.0%
RBC ≤ 1.9%
HGB ≤ 1.9%
MCV ≤ 0.4%
PLT ≤ 4.0%
Table 1-6
Linear Range:
Measuring Measurement of the linear

Parameter
range tolerance
WBC 0~5.9×109/L (±0.3×109)/L
8
Measuring Measurement of the linear

Parameter
range tolerance
6.0~99.9×109/L ±5%
0~0.99×1012/L (±0.05×1012)/L
RBC
1.0~9.99×1012/L ±5%
0~99g/L ±2.0g/L
HGB
100~300g/L ±2%
0~99×109/L (±8.0×109)/L
PLT
100~999×109/L ±10%
Table 1-7
Screen display and the parameter ranges for report output
Parameter
Parameter Parameter Parameter Range
Range
WBC 0.0-99.9x103/μL NEUT# 0-99.9x103/μL
RBC 0.0-9.99x106/μL HCT 0.0-100%
HGB 0.0-30g/dL MCH 0.0-999.9pg
PLT 0-3000x103/μL MCHC 0.0-99.9g/dL
MCV 0-250fL RDW-SD 0.0-99.9fL
LYM% 0-100% RDW-CV 0.0-99.9%

MID% 0-100% PDW 0.0-30.0%
9
Parameter
Parameter Parameter Parameter Range
Range
NEUT% 0-100% MPV 0.0-30.0fL
LYM# 0-99.9x103/μL PCT 0.0-9.99%
MID# 0-99.9x103/μL P-LCR 0.0-99.9%
Table 1-8
Operation Condition
Temperature: 18℃-35℃
Humidity: 10%RH-90%RH
Atmospheric Pressure: 70.0kPa-106.0kPa
Storage and Transportation Condition
Temperature: -10℃-55℃
Humidity: 10%RH-90%RH
Atmospheric Pressure: 50.0kPa-106.0kPa
This instrument should be placed at a good ventilation area.
Electric Specifications
Power Supply:
10
100-240V～, 50/60Hz, auto adapt according to the input voltage
Fuse: F6.3AL250V
Dimension and Weight
Dimension: 410mm×435mm×472mm (L×W×H)
Net weight: 21kg
1.4 Structure
1.4.1 Front Panel
11
1. Touch screen 2. Power light 3. Sample probe
4. [Start] key 5. Thermal recorder
Figure 1-1 Front view of the analyzer
1.4.2 Rear Panel
2
3
12
1.VGA interface 2.USB port 3.Power switch
4.Fuse mounting 5.Socket for power 6.Waste sensor

position input connector
7.Lyse connector 8.Diluent connector 9.Waste connector
Figure 1-2 Rear view of the analyzer
1.5 Operation
Designed according to human engineering and transferring information
to users by software windows and mouse, both are convenient for your
operating.
1.5.1 Display Screen

The display screen is classified into four sections:
13
1 2
4
1. Measurement mode/system time section
Display the Logo of the measurement mode/system time.
2. Shortcut key section
Display the function interfaces of the system.
3. Windows display section
Display various results.
4. Auxiliary information section
Fault information prompt area.
1.5.2 Menu
You can operate the instrument by button. In the ‘Measure’ menu,
14
press “Menu” button, the main menu window pops up, as shown in
Figure 1-3.
Figure 1-3
The button functions are as follows:
Measure: Used to test sample.
Calibration: Used to calibrate the instrument for correct test results.
(1) Operator: Enter the operator calibration window to calibrate the

instrument manually.
(2) Auto: Enter the auto calibration window to calibrate the instrument
15
automatically.
QC: Enter the quality control window to carry out quality control
operation.
(1) Edit: Enter the QC edit window to edit the QC parameters.
(2) Run: Enter the QC run window to carry out the selected QC files.
(3) L-J Graph: Enter the QC graphs window to browse the selected
QC graphs.
(4) List: Enter the QC table window to browse the selected QC tables.
Setting: Enter the setting menu.
(1) Language: Enter the language setting window to set the language
of the instrument.
(2) Time: Enter the time setting window to set the time of the
instrument.
(3) Print: Enter the printout window to set the functions such as print
or report.
(4) Control: Enter the config window to set the functions such as print,
standby, clean, and display etc.
(5) Limits: Enter the limits window to modify the limits.
16
(6) Department Info: Enter the department window to set the

department and abbreviation.
(7) Doctor Info: Enter the operator window to set the department,
abbreviation, department and operator.
(8) Window Color: Select the background color.
(9) Screen Calibration: Calibrate the screen.
Service: Enter the service menu.
(1) Flush: To get rid of the aperture clog.
(2) Enhanced Flush: To get rid of hard aperture clog.
(3) Cleaning: Run the normal rinse process to rinse the measurement
unit.
(4) Prime Chamber Outside: Inject the solutions into the counter
chambers.
(5) Drain Chambers: Empty the liquid of the counter chambers.
(6) Drain All: Run the Drain All program to rinse and empty the tubing.
(7) Prime Diluent: Inject the diluent into the appointed tubing.
(8) Prime Lyse: Inject lyse to the appointed tubing.
17
(9) Prime: Inject the solutions.
(10) Maintenance: Run the maintenance program to maintain the

instrument.
(11) Mechanic: Enter the Mechanic window to verify the functions of the
instrument.
(12) Special: Enter the Special window to maintain the instrument.
Review: Enter the review menu.
Help: Access the system help window.
About: Display information of the instrument such as software and

copyright etc.
Shutdown: Startup the shutdown program to rinse the measurement

unit automatically.
1.5.3 Version Information

In the main menu window, press “About” button to view the software
version and copyright, as shown in Figure 1-4. The version displayed
in the figure only applies to this manual. For the specific version
information, please refer to the instrument you received.
18
Figure 1-4
1.6 Detection Principle

1.6.1 Detection Principles of WBC, RBC and PLT
The count principle of the instrument is based on the measurement of
changes in electrical resistance produced by a particle passing through
an aperture sensor.
(1) The sample blood is diluted in a conductive liquid. As blood cells

are non-conductive, the diluent is a good conductor. There are big
differences between them.
(2) When the diluent passes through the aperture sensor, electrodes
19
are submerged in the liquid on each side of the aperture to create

continuous current.
(3) When cells pass through the aperture, the resistance between the
electrodes increases as the cell volume increases, as shown in
Figure 1-4. According to the Ohm’s law: U=RI (U=Voltage,
I=Current, R=Resistance). If I is a constant, U increases as the cell
volume increases.
(4) Passing through the magnification circuit, the voltage signal will be
magnified and the noise will be filtered, then you will gain the
analytical results, as shown in Figure 1-5.
(5) One counting chamber and the detection circuit count the WBC.
Another counting chamber and the detection circuit count the RBC
and PLT. The microprocessor of the instrument calculates and
analyzes the cells (WBC, RBC, PLT), and then gives out the
histograms.
(6) PLT count adopts advanced liquid, electronics and software

system. It settles the repetitive counting of the cells on the side of
the aperture counting area.
20
Diluent
Constant negative pressure
Voltage Analytical
circuit
Electrode
Constant
current source
Time
Pulse
Figure 1-5
1.6.2 Detection Principle of HGB

Adding lyse in the blood, the red blood cell will rapidly be broken down
and release hemoglobin. Hemoglobin and lyse form a new mixture,
which can absorb the wavelength of 540nm. Measure the absorbency.
Through comparison of the absorbency between the pure diluent and
the sample, the concentration of the sample hemoglobin is calculated.
1.6.3 Volume Distribution of Blood Cell

When different types of cells pass through the aperture sensor, there
will be different electrical pulse height. Because of the evident
difference of the cells sizes, the instrument is able to differentiate the
WBC, RBC and PLT by its pre-set program.
21
The volume distributions are as follows:
WBC: 20-1000fL
RBC: 82-98fL
PLT: 2-35fL
The leucocytes disposed by lyse can be divided into three types,

according to their volumes: lymphocyte (LYM), mid-sized cell (MID),
Neutrophil (NEUT).
LYM: 35-90fL
MID: 90-160fL
NEUT: 160-450fL
1.6.4 Results and Calculation of Parameter

Measurement
The parameters of the sample blood test can be described in three
ways:
(1) Measured directly, such as WBC, RBC, PLT, and HGB.
(2) Derived from histograms, such as LYM%, MID%, NEUT%, MCV,

RDW-SD, RDW-CV, MPV, PDW, P-LCR.
(3) Calculated, such as LYM#, MID#, NEUT#, HCT, MCH, MCHC,
22
PCT.
The derivation of the formularies as follows:
MCV derives from histograms and the instrument collecting and

classifying the erythrocytes according to its volume. It is determined by
measuring the average volume of individual erythrocytes, and the unit
is fL.
RDW represents the volume distribution of the erythrocyte populations,
derived from the RBC histogram. It can be expressed by the coefficient
variation of the erythrocyte volume as RDW-CV, and the unit is %. It
can also be expressed in standard deviation of the erythrocyte volume
as RDW-SD, and the unit is fL.
MPV is the average volume of individual platelets, derived from the
PLT histogram. It represents the mean volume of the PLT populations
and can be expressed in fL.
PDW derives from the PLT histogram. It represents the geometry
standard deviation (GSD) of the volume of the PLT populations.
P-LCR derives from the PLT histogram. It represents the ratio of the
larger PLT, and the unit is %.
HCT (%) = RBC × MCV/10
MCH (pg) = 10 × HGB/RBC
MCHC (g/L) = 100 × HGB/HCT
PCT (%) = PLT × MPV/10
23
LYM% = 100 × AL / (AL+AM+AG)

MID% = 100 × AM / (AL+AM+AG)
NEUT% = 100 × AG / (AL+AM+AG)
LYM# = LYM% × WBC/100
MID# = MID% × WBC/100
NEUT# = NEUT% × WBC/100
AL: Number of cells in LYM area;
AM: Number of cells between lymphocyte and neutrophil area;
AG: Number of cells in NEUT area.
24
Installation
Chapter 2 Installation
2.1 Package
If packing damage is discovered after receiving the instrument, or the
instrument is badly damaged, contact with the freight agent
immediately to file a claim according to the damage level. At the same
time contact with your supplier to make sure the packing is complete.
Then unpack and install the instrument according to the following
steps.
2.2 Unpack
Take out the instrument and accessories from the packing box carefully.
Preserve the packing material for future transportation or storage.
(1) Check the accessories according to the packing list.
(2) Check whether there are mechanical damages on the instrument

and accessories.
If there is any problem, please recover the package and contact with
your supplier immediately.
25
Installation
2.3 Installation Requirements
Installation Environment
The instrument should be placed on a clean steady platform. Keep

away from direct sunlight and dust.
Temperature: 18℃-35℃
Humidity: ≤70%
Atmospheric pressure: 70.0kPa-106.0kPa
Caution:
 The instrument should avoid direct sunlight.
 The working environment of the instrument should avoid powerful
equipment such as centrifuge, CT machine, NMR equipment,
X-ray machine etc.
 Do not use equipment that may create strong radiation field such
as mobile phone and cordless telephone. Strong radiation field will
disturb some functions of the instrument.
Space Requirement
At least 20cm on each side is the preferred access to ensure good
airiness.
Notice:
Reagents must be placed at the same working height as the
instrument.
26
Installation
Power Requirement
The power requirement is as follows:
100-240V～, 50/60Hz
The maximum power consumption is 150VA
Warning:
 The instrument requires a single well-grounded power socket. Its
grounding voltage is no more than 0.5V.
 A grounded outlet is required to connect with the grounding pole
on the rear panel. Make sure of the reliability of the power
grounding at working site.
Caution:
 Fluctuating electric will badly decrease the performance and
reliability of the instrument.
 Proper action such as the installation of UPS (self-preparation)
should be taken before use.
First Installation Notice
(1) Open the right door, cut the ties binding to the sampling module
and remove the ties.
(2) Remove the protective film on the injection ports of the chambers.
(3) Close the right door.
(4) Remove this Notice.
27
Installation
(5) Turn on the power.
2.4 Reagent Tubing Connection

There are three tube connectors with color of white, green and red on
the rear panel of the instrument.
2.4.1 Lyse Connection

Take out the lyse tube with red connector from the accessory kit.
Connect the red lyse tubing connector with the tubing connector of the
same color on the rear panel of the instrument.
Place the other end of the lyse inlet tubing into lyse container, and turn
the container cover until secure.
2.4.2 Diluent Connection

Take out the diluent tube with green connector from the accessory kit.
Connect the green diluent tubing connector with the tubing connector
of the same color on the rear panel of the instrument.
Place the other end of the diluent inlet tubing into diluent container, and
turn the container cover until secure.
2.4.3 Waste Connection

Take out the waste tube with white connector from the accessory kit.
Connect the white waste tubing connector with the tubing connector of
the same color.
Connect BNC plug with BNC socket marked “WASTE” on the rear
panel of the instrument, turn the waste container cover clockwise until
28
Installation
secure.
Caution:
 After completing all the tubing installation, keep the tubing natural
state, without distortion, folding, and twist.
 All the tubing connectors must be installed manually. Forbid using
any tool.
 The reagent must be supplied with the instrument. Otherwise it
may easily cause inaccurate measurement results and incorrect
classification of the blood cell, or make the tubing system badly
damaged.
 Keep the reagent from direct sunlight.
 After replacing the reagent container, discard the rest of the
reagent in the former container. Forbid putting the rest of the
reagent into the replacing container. Avoid polluting the new
replacing reagent.
 When replacing the reagent, avoid making the plastic tube
inserted into the reagent container or contacted with other things.
Avoid polluting the new replacing reagent.
 Avoid using frozen reagent.
 Avoid using the reagent out of its expiration date.
Warning:
Handle and dispose of the waste according to acceptable laboratory,
local state and national standards.
29
Installation
2.5 Recorder Paper Installation
1) Tear down the gummed paper from the door of the recorder.
2) Gently press the door of the recorder to open it.
3) Insert the new paper into the paper entry and make the printing
side towards the thermal head.
4) When the paper juts out from the other side, pull it out and keep it
straight.
5) Pull the paper out of the paper exit.
2.6 Keyboard and Mouse Installation

Take out the keyboard, mouse cushion and mouse from the packing
box carefully.
Plug keyboard cable into the interface marked with . Plug mouse
cable into the interface marked with on the rear panel of the
instrument.
The keyboard and mouse can be placed where it is convenient for your
operating. We suggest that the keyboard placed under the display
screen of the instrument, the mouse cushion at the right side of the
keyboard, and the mouse on the mouse cushion.
30
Installation
2.7 Printer Installation (Optional)

Take out the printer from the packing box carefully. Install the printer
according to the printer manual.
Notice:
The printer cable can only be connected to the interface marked with
on the rear panel of the instrument.
2.8 Power Cable Connection

Make sure the power switch on the rear panel of the instrument is off
(O). Insert one end of the power cable into the power cable interface
on the instrument, the other end into the power socket.
Connect the ground cable to the grounding port on the instrument.
Warning:
Ensure that the power is suitable for the instrument before connection.
31
Sample Analysis
Chapter 3 Sample Analysis
3.1 Preparation before Startup

Every time before startup, the operator should do the following checks:
(1) Whether the diluent and waste tubing are distorted, folded or
twisted, and whether the connection is secure.
(2) Whether the power cable connection is secure.
(3) Whether the accessory connection is secure.
3.2 Startup
If external printer is equipped, turn on the printer power and ensure
they are in ready status.
Press the power button on the rear panel of the instrument, then the
power lamp on the front panel of the instrument lights on. The
instrument automatically performs initialization program.
After completing initialization, the instrument will enter into the self-test
window. It tests the working conditions of each part and if there are
enough diluent and lyse. Simultaneously prime and clean the tubing.
After self-test, the instrument will enter into the ‘Measure’ menu, as
shown in Figure 3-1.
32
Sample Analysis
If the system detects malfunction, the failure information will be

displayed on Information Section.
Figure 3-1
Info: Used to set patient information.
Print: Used to print report.
Flush: To get rid of the aperture clog.
Func: Used to change sample type, adjust classification line for

current result and dispense diluents for prediluted test mode.
33
Sample Analysis
Menu: Used to get into the main menu.
3.2.1 Function
In the ‘Measure’ menu, press “Func” button to enter into the “Function”
window, as shown in Figure 3-2.
Figure 3-2

Sample Type: Select the sample type among Venous, Capillary and
Prediluted, as shown in Figure 3-3.
34
Sample Analysis
Figure 3-3
If select “Prediluted”, the “Function” window changes, as shown in

Figure 3-4.
35
Sample Analysis
Figure 3-4
Diluent: Inject the diluent quantitatively by sample needle. This menu is
used only in Prediluted mode, and “Diluent” button will not display in
other modes.
Histogram: Enter the histogram adjustment window of the current
sample. You can manually adjust the histograms of the current
sample.
3.3 Background Test

Background test is recommended after the instrument starts up
normally every time. The operator can also perform background test in
need. The operating procedures are as follows:
36
Sample Analysis
(1) In the ‘Measure’ menu, press “Info” button, the information editing
window pops up. Click the item textbox to change the ID as 999,
then press “Ok” to return to the ‘Measure’ menu.
(2) In venous or capillary mode, press the “START” key below the
sample needle directly for background count. In prediluted mode,
the sample needle aspirates some non-contaminated diluent from
the sample cup for background count. The diluent pick-up method
is as follows. Analyzing sample in prediluted mode is also
necessary to dilute sample with the diluent which is previously
picked-up in this method:
(1) Press “Func” button to select “Sample Type”, set “Prediluted”

as the sample mode.
(2) In menu operation area, select “Diluent”.
(3) Place a clean empty sample cup or tube under the sampling
needle, press “START” key to dispense the diluent into the
sample cup. Press the “START” key once, the diluent is
dispensed into the sample cup or tube once. The quantity can
be used for background count in the second prediluted mode.
Press “Exit”, the instrument returns to the main operation
area.
37
Sample Analysis
(3) Permissive ranges of the background test results are shown in

Table 3-1.
Parameter Data
WBC ≤ 0.2109/L
RBC ≤ 0.021012/L
HGB ≤ 1g/L
HCT ≤ 0.5%
PLT ≤ 10109/L
Table 3-1
If the value of the background test exceeds the permissive range,

repeat the above testing procedures until the testing result is
acceptable. If the test has been carried on for more than five times, but
the testing result still cannot reach the standard required, please refer
to Chapter 10 “Troubleshooting” in this manual.
Notice:
 Only five parameters WBC, RBC, HGB, HCT and PLT can be
tested and displayed in background test.
 The serial number 999 is a special number for background test.
38
Sample Analysis
3.4 Quality Control

It is necessary to perform quality control in installation for the first time
or before sample analysis every day. Further information and
procedures are specified in Chapter 4 “Quality Control”.
3.5 Preparation for Sample Collection

The sample can be collected either from capillary blood or from venous
blood.
3.5.1 Venous Blood Collection

It is possible to collect venous blood by using negative pressure tube
or with common collecting method.
Add some anticoagulant in advance to the container for venous blood
collection. EDTA-K2·2H2O is commonly used as the anticoagulant,
whose specified content is 1.5-2.2mg/mL blood.
3.5.2 Capillary Blood Collection
(1) Gently massage the blood collection part to make it congest

naturally, wipe the partial skin with tampon containing 75%
alcohol, then air.
(2) Pinch the puncturing part, and puncture it with aseptic sample
needle quickly. The puncturing depth is about 2-3mm.
(3) Wipe off the first drop of blood, and then start the collection.
39
Sample Analysis
(4) Press the wound with tampon for a moment after finishing the
collection.
Notice:
The capillary blood collection should follow the professional capillary
blood collection standard. The general method is partial centesis. The
typical collection is puncturing from the tip of the finger.
Caution:
If the blood flows not freely, press far away from the wound, not around
the wound. Avoid making the histiocyte mixed into the blood, which
may lead to incorrect analytical result.
3.5.3 Prepare Samples in Prediluted Mode
(1) In the ‘Measure’ menu, press the “Func” button, select “Sample
Type”, set “Prediluted” as the sample type, then press “Function”
button. In menu operation area, select “Diluent”.
(2) When the “Diluent” pops up, place a clean sample cup obliquely
under the sampling needle. Press “START” key. The instrument
starts to add diluent quantitatively. Scrape the drops at the top of
the sample needle into the sample cup, collect 20μL capillary
sample in pipette. Wipe the blood attached on the outer layer of
the pipette with clean tissues. Immediately mix up the sample in
the diluent sample cup.
40
Sample Analysis
Caution:
When adding the diluent, the sample cup must be placed obliquely
under the sample needle, which allows the diluent to run down the cup
wall without forming air bubbles.
Notice:
If there is a need to prepare samples in quantities in prediluted mode,
users can use the “Diluent” function to continuously prepare the
diluent.
3.5.4 Prepare Samples in Capillary Mode

Collect 40μL capillary sample in pipette. Immediately mix up the
sample in anticoagulated warhead sample cup. You can also add the
capillary blood to the anticoagulated warhead sample cup directly.
3.5.5 Sample Mixing

The blood samples must be fully mixed before use. The recommended
method is: Shake up the tube up and down for 3~5 minutes, blood
mixer is recommended to make the sample be fully mixed and ensure
the accuracy of measurement.
Caution:
 If the sample has been placed for a long time or mixed
inadequately, it will easily cause measurement error and incorrect
testing results.
 Avoid shaking up the pipette violently.
 The sample to be tested can only be stored at room temperature,
41
Sample Analysis
and the test must be finished within 4 hours.
3.6 Sample Count and Analysis

After finishing sample collection, perform count and analysis procedure
as follows.
3.6.1 Sample Information Input

 Manual Input Information
In the ‘Measure’ menu, click “Info” button, the information editing
window pops up. Move the cursor to the required inputting item textbox.
Input or select the data, and press “Ok”. The instrument will save the
input information and returns to the ‘Measure’ menu. Press “Cancel”
button, the instrument cancels the input information and returns to the
‘Measure’ menu.
Name: Maximum 19 characters.
Sex: Select male or female, and the default is blank.
Age: Choose from year, month and day. There are maximum 3
numbers while choosing year and day, maximum 2 numbers while
choosing month.
Blood Type: Choose from A, B, O, AB, A RH+, B RH+, O RH+, AB
RH+, A RH-, B RH-, O RH-, AB RH-, the default is blank.
Sample: The current sample mode.
Record No.: Maximum 15 characters.
Bed No.: Maximum 15 characters.
42
Sample Analysis
ID: The input range is: 001~998. The instrument owns an intelligent
number manager. The final number derives from the comprehensive
information that the instrument adds the information of year, month
and day in front of the input number according to the measured time. If
user does not input the serial number, the instrument will accumulate
the number from 001 everyday according to the measured time.
Department: You can also choose the recorded department
information from the right optional textbox, or choose automatically by
the instrument after inputting the code of the department in the left
input textbox.
Doctor: You can also choose the recorded doctor information from the
right optional textbox, or choose automatically by the instrument after
inputting the code of the doctor in the left input textbox.
Operator: You can also choose the recorded doctor information from
the right optional textbox, or choose automatically by the instrument
after inputting the code of the doctor in the left input textbox.
Checker: You can also choose the recorded doctor information from
the right optional textbox, or choose automatically by the instrument
after inputting the code of the doctor in the left input textbox.
Limits: Choose from General, Man, Woman, Child, Newborn, Define 1,
Define 2, and Define 3 automatically. Set the low and high limits of the
corresponding parameters.
43
Sample Analysis
Notice:
 The number 999 is a special number for background test. Please
don't input this number in blood sample test.
 If there is a need to input the sample test information in quantities,
users can concentrate on inputting the sample test information in
the review window after the current sample test finished.
3.6.2 Procedures of Sample Count and Analysis
(1) Place a sample cup under the sample needle, press “START” key,
the instrument starts to aspirate the liquid.
(2) The instrument starts to analyze the sample automatically. Please

wait for the analytical result.
(3) After the analysis finished, the result will be displayed behind the
corresponding parameters on ‘Measure’ menu of the instrument,
with histograms WBC, RBC, and PLT.
If “Auto” item is “ON”, the recorder or printer will output the test results
automatically.
If there are clogs during the count and analysis process, the
information section would display “Clog”.
3.6.3 Parameter Alarm

“C”: To indicate that clog appears in the test.
Blue parameter result: To indicate that the data has exceeded the set
44
Sample Analysis
lower alarm limit of the parameter.

Red parameter result: To indicate that the data has exceeded the set
higher alarm limit of the parameter.
“***”: To indicate that the data is invalid.
Notice:
 When PM alarm occurs on PLT histogram, the result of parameter
PDW is “***”.
 If the result of WBC is less than 0.5×109/L, the system will not
perform leukocyte differential. The display for all parameters
related to leukocyte differential is “***”.
3.6.4 Histogram Alarm

“R1”: To indicate the abnormality of the lymphocyte hump on the left. It
may present platelets coagulate, large platelet nucleated red cell,
insolvable red cell, abnormal lymphocyte, protein etc.
“R2”: To indicate the abnormality between the lymphocyte and the
mid-sized cell area. It may present atypical lymphocyte, abnormal
lymphocyte, plasma cell, original cell or the increase of the number of
the eosinophil or basophil.
“R3”: To indicate the abnormality between the mid-sized cell and
neutrophil. It may present immature neutrophil, abnormal
sub-population in the sample, or the increase of the number of the
eosinophil.
“R4”: To indicate the abnormality on the right of neutrophil area. It
45
Sample Analysis
shows the increase of the number of the neutrophil.

“RM”: To indicate that more than two areas occurs abnormality. The
upper reasons exist simultaneously.
“PM”: To indicate the abnormality and the blur demarcation between
platelet and red blood cell area. Large platelet, platelet coagulation,
small red blood cell, cell debris or fibrin may exit.
3.7 Analytical Results Modification

If users think that the results of WBC, RBC, and PLT differential cannot
meet the needs of the classification of special samples in clinical or
laboratory, they can manually adjust the histograms.
Operate as follows:
(1) In the ‘Measure’ menu, select “Func”, then press “Histogram”, the
instrument enters into the histogram adjustment window, as
shown in Figure 3-5. Press “Para” button to adjust the histogram.
46
Sample Analysis
Figure 3-5
(2) After selecting the histogram, press “Line” button, and select the
sorting line you want to adjust.
(3) Press “Left” or “Right” button, you can move the sorting line to the
left or right, the data of the line will be displayed at the top right
corner of the screen.
(4) Press “Back” button when the adjustment finished. If this

operation did not change any data, the system would return to the
‘Measure’ menu directly, or else pops up the “Ok/Cancel” window.
Press “Ok” to save the adjustment result, while select “Cancel” to
47
Sample Analysis
cancel the adjustment result.
Caution:
Unnecessary and incorrect manual adjustment will cause unreliable
analytical result. Make sure the necessity of the operation.
Notice:
If the result of WBC is less than 0.5x109/L, the system will not perform
leukocyte differential automatically.
3.8 Shutdown
Shutdown routine must be performed before turning off the power
every day.
During shutdown procedure, the instrument will perform daily
maintenance and clean the tubing automatically.
The procedures are as follows:
1) In the ‘Measure’ menu, press “Menu” button, then select

"Shutdown" button, the shutdown window pops up.
Figure 3-6
48
Sample Analysis
2) If you do not want to shutdown the instrument for the moment,

click “Cancel” to return to the main menu window.
3) Press “Ok”, the instrument will perform daily maintenance and

clean the measuring tubing. When the shutdown procedure
finished, the screen displays “PLEASE TURN OFF THE
POWER!”, turn off the power on the rear panel of the instrument.
Figure 3-7
4) Turn off the printer power (if equipped), clean the workbench and
dispose the waste.
Notice:
Do not turn off the power of the instrument directly while performing the
shutdown procedures.
49
Quality Control
Chapter 4 Quality Control
Quality Control means the precision, accuracy and repeatability of the

system. Quality control provides reliable and effective methods for the
possible system errors in detection and prevention. The system errors
may cause unreliable analytical result of the sample. To maintain the
reliability of the analytical results, periodic quality control of the
instrument is required.
The instrument provides 9 QC files for users. It allows the operator to
run quality control for the 12 parameters at the same time.
First select a QC file, enter the assay and limit of control data. The
system allows the operator to run quality control for the 12 parameters
simultaneously or for some of the 12 parameters.
Caution:
 Quality controls must be stored in appropriate conditions.
 Do not use quality controls deteriorated or out of its expiration
date.
 Be sure to finish the quality control in a certain time every day.
4.1 Edit Quality Control Files

The operating procedures are as follows:
1) In the main menu window, press “Quality Control” button, then
50
Quality Control
select “Edit” in the menu. The instrument enters into the quality
control edit window, as shown in Figure 4-1.
Figure 4-1
2) In quality control edit window, select the QC file you want.
3) Input lot number and expiration date of the control, the assay and
limit of the quality control parameters.
4) Press “Save” button to save the data of the current QC file.
5) Press “Delete” button to delete the data of the current QC file.
6) Press “Back” button to save the data of the current QC file and
return to the quality control edit window.
51
Quality Control
Notice:
 If the parameter is zero, the system will take the assay and limit as
no assignment. If the parameter exceeds the display range, the
system directly displays the maximum value in the display range.
It needs to re-input. Or else the quality control will only act on
other parameters.
 If the lot number or expiration date is invalid, the system will take
them as no assignment. It needs to re-input. Or else the QC file
cannot run quality control program.
4.2 Quality Control Run

Input QC parameters and perform QC run of the specified file.
The operating procedures are as follows:
1) In the main menu window, press “Quality Control” button, then

select “Run” in the menu and select the QC file you want. The
instrument enters into the quality control run window, as shown in
Figure 4-2.
2) Prepare the controls and shake up the container until it

well-mixed.
52
Quality Control
Figure 4-2
3) Place the controls under the sampling needle. Press “START” key,
the indicator lamp starts to glitter, the instrument aspirates the
controls, move the controls away until the indicator lamp stops
glittering.
4) When the test finished, the result will be displayed on the column
of the current window. If alarm occurs during the test, the current
result may be incorrect.
5) Press “Del” button to delete the result and test again after the
problem is solved.
6) Press “Back” button, the instrument will return to the ‘Measure’
53
Quality Control
menu.
Notice:
Each QC file can store up to 31 QC data.
4.3 Quality Control Graph

The graph provides a visual observation of the control data, allowing
operators to observe the possible deviations, trends or shifts of the
instrument performance.
In the main menu window, press “QC” button, then select “L-J Graph”
in the menu and select the QC file you want. The instrument enters into
the quality control graph window, as shown in Figure 4-3.
Figure 4-3
54
Quality Control
The screen can display QC graph of one parameter. The graph shows
the lot number, date, serial number, QC mode and distribution of the
QC data. Click the scroll bar on the right side of the screen, and
continuously select the QC graph of different parameters.
The seven parameters at the left side of the QC graph from top to
bottom:
Assay + 3limit
Assay + 2limit
Assay + limit
Assay
Assay - limit
Assay - 2limit
Assay - 3limit
The three parameters at the right side of the QC graph from top to
bottom:
Mean: average value
Diff: standard deviation
CV: coefficient of variation
The vertical line in the middle of the QC graph indicates the current
chosen number. Click the scroll bar on the left side of the screen to
continuously select the different number.
The chosen number is displayed in the data box below the
corresponding parameter. The test time for the chosen number is
55
Quality Control
displayed in the time box on the screen.

In the QC graph window, the following marks represent:
The mark “*” between the broken line represents that the point is within
control range. Otherwise it is out of control range.
The mark “.” represents that the parameter value is outside the
operating range, or error has occurred during the run. Blank represents
that there is no quality control on running.
Press “Print” button, it will print the data of the parameters which you
select.
Press “Back” button to return to the ‘Measure’ menu.
4.4 Quality Control List

The instrument supplies tabulated format for QC review. In the main
menu window, press “Quality Control” button, then select “List” in the
menu and select the QC file you want. The instrument enters into the
quality control list window, as shown in Figure 4-4.
56
Quality Control
Figure 4-4
The screen can display 12 QC parameters of 7 groups at the same

time.
Click the scroll bar to select different serial number.
Press “Print” button, it will print the data of the parameters on the
screen.
Press “Back” button to return to the main menu window.
57
Calibration
Chapter 5 Calibration
The instrument has been calibrated strictly at the factory. You may
need to perform calibration procedures when you replace any
component that involves the primary measurement characteristics, or
when the shift occurs during controls. Calibration of the instrument is to
provide the assurance that the instrument is providing results with
accuracy as design. The purpose of calibration is to ensure the
accuracy of the measurement result to meet the requirement of the
design all the time.
To ensure the measurement accuracy of the instrument and obtain
reliable results, it is necessary to calibrate the instrument in the
following situations:
1) Installation for the first time or re-setup in a new place.
2) The instrument is maintained.
3) The result of quality control is abnormal.
4) Replace reagent.
Warning:
Calibrators should be stored and used properly according to the
calibrator manual.
58
Calibration
Warning:
Make sure the instrument is in a normal state before calibration.
Warning:
Avoid using the measurement result on medical test or clinical before
the calibration is finished accurately.
Check the instrument and reagents carefully before calibration. Make
sure the instrument is in normal status, and the required sample mode
of the measurement is selected.
5.1 Operator Calibration

5.1.1 Background Test
Refer to section 3.3 in Chapter 3 “Sample Analysis”, ensure that the
background test meets the requirement and no malfunction occurs.
5.1.2 Assurance of Repeatability

To ensure the calibration accuracy, it is necessary to evaluate the
measurement repeatability of the instrument. Make sure the instrument
is in normal status, then perform calibration program.
1) In the ‘Measure’ menu, measure repeatedly with the calibration for

no less than 3 times.
2) Record the data of WBC, RBC, HGB, MCV and PLT. Calculate
the CV value according to the following formula. Only results in
59
Calibration
the limit of Table 5-1 can perform calibration.
 (X
i 1
i  X )2
CV  n 1  100%
X
x -- Average value of the test results
x i -- Test result of the ith test
n – Test times of the sample
Parameters CV (%)
WBC ≤ 2.0
RBC ≤ 1.9
HGB ≤ 1.9
MCV ≤ 0.4
PLT ≤4
Table 5-1
60
Calibration
5.1.3 Calculate Calibration Factors

Calculate the new factors according to the following formula:
Current factor  Reference value

New factor 
Average value
5.1.4 Modify Calibration Factors
1) In the ‘Measure’ menu, press “Menu” button, select “Calibration”

in the menu, then select “Operator” button to enter into the
calibration window, as shown in Figure 5-1.
Figure 5-1
61
Calibration
2) Select the needed calibration data from the calibration data menu
box.
3) Press “Print” button. The instrument will print the current

calibration result.
4) Press “Ok” button to save the current calibration result and return
to the main menu window.
5) Press “Cancel” button. The instrument will cancel the current

calibration result and return to ‘Measure’ menu.
5.2 Auto Calibration

1) In the ‘Measure’ menu, press “Menu” button, select “Calibration”

in the menu, then select “Auto” button to enter into the calibration
62
Calibration
Figure 5-2
2) Input the reference value of each calibration parameter.
3) Prepare the calibrators and shake up the container until it is

well-mixed.
4) Place the calibrators under the sample needle. Press “START”

key, the instrument aspirates the calibrators. Move the calibrators
away until it stops.
5) When the measurement finished, the result will be displayed on

the column of the current window. If alarm occurs in measurement,
the current result may be incorrect.
63
Calibration
6) Press “Del” button to delete the result and test again after the
problem is solved.
7) Press “Back” button, the instrument will return to the ‘Measure’

menu.
Notice:
 Calibration can be performed 5 times at the most.
 The calibration result will be displayed after testing 3 times.
 If the parameter contains invalid data, the system will not perform
calibration. It needs to re-input valid data.
64
Setting
Chapter 6 Setting
The instrument has accomplished all the settings at the factory. For
customer's convenience, most of the system parameters can be set by
operators so as to meet various requirements.
Notice:
Operations in this chapter will change the running state of the
instrument. Make sure of the necessity of changing before operating.
6.1 Date & Time

In the ‘Measure’ menu, press “Menu” button, select “Setting” in the
menu, then select “Time”. The instrument enters into the time setting
window, as shown in Figure 6-1. Click the menu bar to adjust the
setting item. Press “Save” to save the current parameters and return to
the setting window. Press “Back” to not save the current parameters
and return to the setting window.
65
Setting
Figure 6-1
6.2 Printout
menu, then select “Print". The instrument will enter into the print
66
Setting
Figure 6-2
Click the menu box you want to adjust, the option window pops up.
Click the item you want to set.
Press “Ok”, the system will save the current parameters and return to
the setting window. Press “Cancel” button, the system will not save the
current parameters and return to the main menu window.
Print select
Select recorder, the data will only be transported to the recorder.
Select serial port, the data will only be transported to the net.
Select recorder and serial port, the data will be transported to the
recorder and net at the same time.
67
Setting
Select Laser Jet, the data will be transported to a printer such as the
HP Laser Jet1018 printer or HP Laser Jet1008 printer.
Select Desk Jet, the data will be transported to a printer such as the
HP desk Jet1668 printer or HP Laser Jet 2668printer.
Laser printer settings
Select LaserJet, as shown in Figure 6-3.
Figure 6-3
Click “Ok” to enter the laser print setting interface, select the print font
(format).
68
Setting
(1) A4 Print
Figure 6-4
When the paper size is A4, it defaults to 24 fonts. Adjust the vertical
distance of the printing layout by setting the distance and size of the
title. The contents occupy almost the entire layout of A4 paper, as
69
Setting
Figure 6-5
70
Setting
(2) A5 Print
Figure 6-6
When the paper size is A5, you can select 12 or 16 fonts. Adjust the
vertical distance of the printing layout by setting the distance and size
of the title. The contents occupy almost the entire layout of A5 paper
and about half of the A4 paper, as shown in Figure 6-7 (take 16 fonts
for example).
71
Setting
Figure 6-7 (A5)
72
Setting
Figure 6-7 (A4)
73
Setting
Notice:
There are different formats when selecting different printer settings.
Print caption
Can easily printout the headline on the report.
Print type
Can choose the type of the printer.
Notice:
The selected printer type must be accord with the used one, otherwise
it will not be able to print normally.
6.3 Control
menu, then select “Control”, the instrument will enter into the control
setting window, as shown in Figure 6-8.
74
Setting
Figure 6-8
Click the menu box you want to adjust, the option window pops up.
Click the item you want to set.
Press “Save”, the system will save the current parameters and return
to the hematology window.
Press “Cancel” button, the system will not save the current parameters
and return to the main menu window.
Auto
Set “Print” as “OFF”, the system will not print the test report
automatically after the sample test finished.
Set “Standby” as “OFF”, the instrument will keep working status all
75
Setting
along. Set “Standby” as data. When the time, which the user does not
perform any operation, exceeds the setting time, the instrument will
access standby state. During standby time, the instrument will turn off
part of the circuit power, and take the sample needle back. Standby
function can greatly save electrical energy and extend the life of the
instrument. Press the left key of the mouse or any key on the keyboard,
standby will be canceled.
Set “Start test” as “OFF”, the system will not perform background test
after booting.
Set “Shutdown immersion” as “OFF”, the system will not perform probe
cleanser soaking after shutdown.
Set “Enhanced Flush” as number. The sample test times interval of the
enhanced flush that controls the automatic maintenance of the
instrument is selected by the pull-down menu.
Sound
Set “Alarm” as “OFF”. When the instrument appears alarm, it will not
make alarm sound, but display the alarm information in the Information
Section.
Set “Alarm” as “ON”. When the instrument appears alarm, it will make
alarm sound and display the alarm information in the Information
Section.
76
Setting
Set “Prompt” as “OFF”. When the sample test finished, the instrument
makes no sound.
Set “Prompt” as “ON”. When the sample test finished, the instrument
will make a prompt sound like “di”.
Display
Set “Para” as “English”. In parameter area of the hematology analyzer,
the parameters will be displayed in abbreviations.
Set “Limits” as “No Display”. In parameter area of the hematology
analyzer, the parameters will not display reference value of the current
sample.
Set “Limits” as “Low-High”. In parameter area of the hematology
analyzer, the reference values will be displayed from low to high.
Set “Limits” as “High-Low”. In parameter area of the hematology
analyzer, the reference values will be displayed from high to low.
6.4 Limits
menu, then select “Limits” to enter into the limits setting window, as
The 8 group reference values are displayed at the left side of the
screen. The dot in front of the reference value represents that this is
the current selected reference group. The limits of the reference value
are displayed in the limits boxes on the screen.
77
Setting
Click the dot in front of the group to select the group required for
setting.
Figure 6-9
Click “Default” button, the instrument will select the default reference
values to replace the current reference values.
Click the adjustable bar of the limits box to adjust the upper and lower
limit of the reference value.
Function of menu buttons:
Save: Save the reference values of the current group.
Print: Print the reference values of the current group.
Back: Exit from current window and return to main menu window.
78
Setting
Notice:
The default reference value may not suitable for the local conditions.
Users can modify it according to the local specific circumstances.
Caution:
The changing of the reference value will cause variation of abnormal
prompt on hematology target. Please make sure the necessity of the
variation.
6.5 Department Information

The department information can help user setup perfect sorting
information in advance, and quicken the input speed and management
of the sample information. Especially the abbreviation greatly improves
the communication and standardization construction of laboratory
digital information.
menu, then select “Department Info”, the instrument enters into the
department setting window, as shown in Figure 6-10.
79
Setting
Figure 6-10
Click the scroll bar at the right side of the window, the instrument can
record the serial number continuously.
Click “Back” button, the system exits from the current window and
returns to the ‘Measure’ menu.
6.5.1 Add record information

Click “Add” button to enter into the record adding window, as shown in
Figure 6-11.
Input the information of department and abbreviation.
Notice:
The coding method of the abbreviation should be easy to memory. In
most circumstances, the abbreviation of the department name is
80
Setting
recommended.
Click “Ok” button to save the current input information. The system
returns to department setting window.
Click “Cancel” button, the current input information will be canceled,
and the system returns to department setting window.
Figure 6-11
6.5.2 Print department information

Click “Print” button to print all the department information saved.
6.6 Operator Information

The operator information can help user setup perfect sorting
81
Setting
information in advance, and quicken the input speed and management

of the sample information. Especially the name greatly improves the
communication and standardization construction of laboratory digital
information. In the ‘Measure’ menu, press “Menu” button, select
“Setting” in the menu, then select “Doctor Info”, the instrument enters
into the operator setting window, as shown in Figure 6-12.
Figure 6-12
Click the scroll bar at the right side of the window to display
continuously the records of different numbers.
Click “Back” button, the system will exit the current window and return
to the main menu window.
82
Setting
6.6.1 Add operator information

Click “Add” button, the instrument enters into the record adding
Figure 6-13
Input the information of name and abbreviation.

Input abbreviation information at the left input box of department, the
system will select department automatically. You can also select the
department directly from the right input box of the department.
“Status” represents the status of the doctor, including: doctor, operator
and checker. Click the box in the left directly, blank means no choice,
black fork means selected. Selecting more than one item is allowed.
83
Setting
Notice:
The coding method of the abbreviation should be easy to remember. In
most cases, abbreviation of the department name is recommended.
6.6.2 Print operator information

Click “Print” button, the instrument will print all the operators
information saved.
84
Review
Chapter 7 Review
The instrument can automatically store the results after each sample
analysis. The operator can review, search, modify, print, and delete the
data.
7.1 Sample Review

In the ‘Measure’ menu, press “Menu” button, then select “Review” in
the menu, as shown in Figure 7-1.
Figure 7-1
The data can be reviewed and printed in table.
85
Review
8 sample parameters are displayed in each review screen in the order

of time sequence.
The button of scroll bars at the bottom of the screen shows the current
position.
The meanings of the characters are as follows:
“↑” is displayed following the parameter indicating that the results
exceed the high limit of the system.
“↓” is displayed following the parameter indicating that the results
exceed the low limit of the system.
“C” is displayed following the parameter indicating that clogs occur
during the test.
Review the sample data
Click the left button of scroll bar at the bottom of the screen to review
the rear data.
Click the right button of scroll bar at the bottom of the screen to review
the front data.
Click the left side of the button at the bottom of the screen to review the
data of the next page.
Click the right side of the button at the bottom of the screen to review
the data of the front page.
Hold the button at the bottom of the screen, and draw the mouse to
review the sample data quickly.
86
Review
Delete the selected data

1) Click the sample ID, the corresponding sample result will be

selected. Click again, the selection will be canceled.
2) Select “Delete” in the menu, a dialog box pops up, and choose to
delete the data or not. Press “Ok” button, the data will be deleted.
Press “Cancel” button, the operation will be cancelled.
Delete all data

1) Click “All” button, the data will be selected. Click again, the
selection will be canceled.
2) Click “Delete” button, a dialog box pops up, and choose to delete
the data or not. Press “Ok” button, the data will be deleted. Press
“Cancel” button, the operation will be cancelled.
Print the current sample data in table

1) Click “All” button at the top of the screen, the data will be selected.
Click again, the selection will be canceled.
2) Click “Print” button, the selected data would be printed in table.
87
Review
Search sample data

Print the selected data as the following procedures:
1) Click “Query” in the menu, the search window pops up, as shown
in Figure 7-2.
2) Click the button on the left of the item to be searched, input the
keyword you want to search.
3) Repeat the b) procedure until the current inputting item finished.

Click “Cancel” button to cancel the searching. Click “Ok” button,
start to search the data. When the searching finished, the proper
sample data will be displayed on the screen.
Figure 7-2
88
Review
The functions of the menu buttons are as follows:

All: select or recover all the sample data.
Detail: Enter the detail review window.
Delete: Delete the selected data.
Print: Print the current data in table.
Query: Search the required sample data in any condition.
Menu: Exit from the current window.
7.2 Detail Review

In the detail review window, click “Detail” button. The instrument will
enter into the detail review window, as shown in Figure 7-3. You can
review, modify and print the sample data in graphs in this window.
Review
Click “Next” button to review the next data.
Click “Prev” button to review the previous data.
Modify sample information
Click “Info” button, “Information” window pops up. Refer to section
3.6.1 in Chapter 3 “Sample Analysis” for the operation of this window.
Modify sample data
Click “Histogram” button in the menu.
The operation procedures are as follows:
1) Click “Para” button to select WBC, RBC, and PLT in turn.
89
Review
2) Click “Line” button to select the sorting lines in the histogram.
3) Click “Right” or “Left” button to move the line to the right or left.
Data calculated according to the new sorting line would be displayed in

the data area at the left side of the screen.
4) Click “Back” button. If the sample data has been modified, a

dialog box pops up. Users can select to save the modification
result or not. Click “Ok” button to save the result. Click “Cancel”
button not to save it and exit from the histogram modification
status.
Figure 7-3
90
Review
The functions of the menu buttons are as follows:

Histogram: Review the histograms.
Info: Input and modify the sample data.
Print: Print the current sample data.
Next: Review the next data.
Prev: Review the previous data.
Back: Exit from the current window and return to the main menu
window.
91
Service
Chapter 8 Service
This chapter gives the description of various service functions provided

by the instrument. These functions will bring user convenience and
pleasure.
In the ‘Measure’ menu, press “Menu” button, then select “Service” in
the menu.
Figure 8-1
8.1 Flush
This function is used to solve general gem hole clog issue. The
92
Service
instrument makes a fixed pressure and voltage act on the gem hole for
a few seconds to eliminate dirt at the holes.
8.2 Enhanced Flush

This function is used to solve gem hole clog issue. Probe cleaner
would be injected into WBC and RBC count chamber. Get rid of the
indolent probe clog by soaking it in the probe cleaner. Before
performing the function, user should prepare the probe cleanser well.
8.3 Cleaning
This function is used to clean the sampling needle and tubes.
8.4 Prime Chamber Outside

This function is used for user to fill the chambers with diluents. Fill the
tube connected to the side of the measuring cup with diluent.
8.5 Drain Chambers

This function is used for user to observe the count chamber. The
instrument will empty the liquid in the count chamber.
8.6 Drain All

The manufacturer suggests you not to use this function. If the
instrument is not going to be used for 2 weeks or longer, use this
function to clean and empty the instrument. Prepare distilled water
before performing this function.
93
Service
8.7 Prime Diluent

Prime diluent to the related tube.
8.8 Prime Lyse

Prime lyse to the related tube.
8.9 Prime
Prime diluents and lyse to the related tube.
8.10 Maintenance
Perform the weekly maintenance according to the prompt information
on the screen. Prepare probe cleanser before maintenance.
8.11 Mechanic
Users can detect the valve, motor, circuit and interface in the
“Mechanic” menu. It is helpful to the detection of malfunctions.
94
Service
Figure 8-2
Valve:
“ON” represents the valve is on. “OFF” represents the valve is off.
Motor:
"OK" represents that the motor is in normal status.
"FAIL" represents the motor has failure.
Recorder:
Click this button, the recorder will print a test paper.
Printer:
Click this button, the external print will print a test paper.
Back:
95
Service
Return to the service menu and the instrument initializes automatically.
Figure 8-3
8.12 Special
The instrument enters special maintenance window. User can adjust
the running control data. This function should be performed in
guidance of the engineers authorized by the manufacturer.
96
Maintenance
Chapter 9 Maintenance
As a precise instrument, only careful daily service and periodic

maintenance can the instrument has a good working status, and can
we get the reliable measurement results and have few malfunctions.
This chapter introduces some preventive methods for service and
maintenance.
If you want to know more related information, please contact the
Customer Service Department of the manufacturer.
According to the requirements for maintenance of the instrument
during the using procedures, the manufacturer divides the preventive
service and maintenance into the following types: daily, weekly,
monthly, yearly and maintenance according to the actual need.
Warning:
It is important for the hospital or organization that employs this

instrument to carry out a reasonable maintenance schedule. Neglect of
this may result in machine breakdown.
9.1 Routine Maintenance

9.1.1 Clean the appearance
Wipe the appearance of the instrument with neutral detergent or
distilled water.
97
Maintenance
Caution:
 Avoid using corrosive acids, alkali and volatile organic solvent,
such as acetone, aether, chloroforms, to wipe the appearance of
the instrument. Only neutral detergent can be used.
 Avoid wiping the inner of the instrument.
9.1.2 Replace fuse

The fuse is installed in the fuse-box on the side of power switch. Open
the box to replace the fuse expediently.
Appointed specification of the fuse: F6.3AL250V
Warning:
Only fuse with the appointed specification can be used.
9.2 Daily Maintenance

It can be divided into two types: running and shutdown.
Running
The instrument has installed daily maintenance procedure. When in
running, it can execute auto-cleaning procedure according to the
quantity of the sample to keep the instrument in good working status.
Set the auto-cleaning procedure according to section 6.3. The general
setting principles are:
Working time > 8 hours, auto-cleaning time = 8 hours;
4 hours <Working time <8 hours, auto-cleaning time = 4 hours;
98
Maintenance
Working time < 4 hours, auto-cleaning time = 2 hours;

The auto-cleaning time will decrease 1 hour year by year.
Shutdown
When the instrument is shutdown, it will run daily shutdown
auto-cleaning procedure. You only need to clean the workbench and
wipe the appearance of instrument when power-off.
9.3 Weekly Maintenance

This instrument has installed weekly maintenance procedure. Act as
follows:
Prepare the probe cleanser well.
‘Measure’ menu → Main Menu → Service → Maintenance
Finish all the operations according to the prompts on the screen.
Turn off the power of the instrument.
Note: Hematology Analyzer is a kind of precise instrument, so it is

recommended to do maintenance every 4 to 5 days. If you have a big
amount of samples, you should increase the maintenance times
appropriately.
99
Maintenance
9.4 Monthly Maintenance

9.4.1 Clean the dust of the instrument every month
Operate as follows:
1) Turn off the power of the instrument, and pull out the power cord.
Open the right side door and brush away the internal dust of the
instrument gently.
Note: We must prevent the dust fall into the measuring cup to
contaminate it and make an abnormal test result.
2) When the cleaning is done, do not use the instrument immediately.

We should start the washing system to make sure the inner side
of the pipeline is cleaned.
9.4.2 Clean the sample probe every month
1) Prepare ethanol (95%) and cotton swabs.
2) Wipe the outer wall of the sample probe with a cotton swab
dipped in alcohol and gently wipe the outer wall of the sample
probe. Do not bend it hard.
3) Wipe the bottom and top of the swab with a cotton swab
dampened with alcohol.
100
Maintenance
4) "Main Menu" → "Services" → "Cleaning", perform two

cleanings.
9.4.3 Clean the shielded box every month
1) Prepare alcohol (75%) and a cotton swab.
2) Wipe the outer wall of the shielding box with a cotton swab dipped
in alcohol and gently wipe the outer wall of the shielding box.
3) Note: Wear gloves when performing the above cleaning

operations to avoid direct contact with the internal parts of the
instrument.
9.5 Yearly Maintenance

It's necessary to perform preventive maintenance once every year.
Because of the high requirements for yearly maintenance, the
maintenance should be performed by engineers authorized by the
manufacturer. Please contact the Customer Service Department of the
manufacturer before yearly maintenance.
9.6 Maintenance before Transport or for the
Instrument that will not be used for a long time

If the instrument hasn’t been used for more than two weeks or need to
be packaged for transportation, do as the following steps:
101
Maintenance
1) The remaining reagents should be covered and tighten. Follow

the instructions to do the reagents’ storage and protection. The
user should establish and maintain effective reagents-storage
measures to prevent the reagents’ deterioration, misuse and be
eaten.
2) Attach the pipe plugs unplugged in the first installation to the line
interfaces on the rear panel of the instrument, according to the
colors’ one to one correspondence.
3) Separately clean the diluent catheters, the lyse catheters, waste

catheters with distilled water, then dry them in a shade place and
package them with plastic bags.
4) Clean the power cable with a clean cloth dampened with neutral
detergents, place it in a shade place and put it in a plastic bag.
5) Put the instrument and plastic bags with components into the
packaging box
After the instrument is not used for two weeks, the maintenance of the
boot:
1) Connect the lyse and the diluent, and select the whole machine
for infusion in the main menu service;
102
Maintenance
2) After the completion of the background test 3 times, confirm that

the blank background test is 0.
103
Troubleshooting
Chapter 10 Troubleshooting
This chapter contains information that is helpful in identifying and

resolving instrument problems that may occur in the operation of the
analyzer. If the problems cannot be corrected with the aid of this
chapter, the user should contact the Customer Service Department of
the manufacturer.
10.1 Abnormal Startup

Methods and procedures:
1) Check if the power is on.
2) Check if the power socket is loose.
3) Check if the fuse is broken. If broken, replace it as section 9.1.2.
10.2 Waste Full

Dispose of the waste in waste container.
10.3 Diluent Empty

104
Troubleshooting
1) Replace diluent.
2) In the ‘Measure’ menu, select “Menu/Service/Prime Diluent”.
10.4 Lyse Empty

1) Replace lyse.
2) In ‘Measure’ menu, select “Menu/Service/Prime Lyse”.
10.5 WBC Clog or RBC Clog

If the count time exceeds high limit of the setting during measurement,
there will be “Clog” alarm.
1) In the ‘Measure’ menu, press “Flush” button.
2) If the upper method could not solve the problem, perform as the
following procedures.
3) In ‘Measure’ menu, select “Menu/Service/Enhanced Flush” and

follow the screen prompt information to finish it.
105
Troubleshooting
10.6 HGB Error

1) In ‘Measure’ menu, select “Menu/Service/Cleaning”.
3) In ‘Measure’ menu, select “Menu/Service/Enhanced Flush”.
10.7 HGB Bubbles

3) In ‘Measure’ menu, select “Menu/ Service/Enhanced Flush”.
10.8 Recorder out of Paper

1) Gently press the recorder door to open it.
2) Insert the new paper into the paper entry, and make the printing
106
Troubleshooting
side towards the thermal head.
3) When the paper juts out from the other side, pull it out and keep it
straight.
4) Pull the paper out of the paper exit.
5) Close the door of the recorder.
10.9 Recorder too Hot

Possible reasons:
The thermal head of the recorder is too hot.
Suspend using the recorder for 5 minutes.
10.10 The Result of Background Test too high

2) If the above method could not solve the problem, repeat the
procedure 3 times. If the problem still cannot be solved, perform
as the following procedures.
3) In ‘Measure’ menu, select “Menu/ Service/Enhanced Flush”.
4) If the above method could not solve the problem, repeat the
107
Troubleshooting
procedure 3 times. If the problem still cannot be solved, perform

the upper procedure after replacing all the reagents.
108
Help
Chapter 11 Help
The instrument provides on-line help during operation. It is helpful for

user to solve common problems and indicate the next operation.
Besides, the instrument provides help for user to read and search the
information in window. In the ‘Measure’ menu, select “Menu/Help”, the
help window will pop up, as shown in Figure 11-1.
Figure 11-1
This window shows in chapter mode. User can search help information
conveniently. Click the scroll bar up and down to read the previous or
next information.
109
Symbol
Appendix 1 Symbol
A 1.1 Symbols on the Instrument

Symbol Meaning Symbol Meaning
COM 1 Interface USB Interface
Equipotential
COM 2 Interface
Terminal
Display Interface Biohazard
High
Keyboard Interface
Temperature
Mouse Interface Caution
Serial number Manufacturer
In vitro
Date of
diagnostic
manufacture
medical device
110
Symbol
CE marking. The
device is fully in
Authorized
conformance with
representative in
the Directive
the European
98/79/EC on in
Community
vitro diagnostic
medical devices
Catalogue number
A 1.2 Product’s Outer Packaging Illustration
——“Fragile”: Carefully carry and place.
——“Up”: Upward to place and transport the product.
—— “Rain proof”: Protect the package from the rain.
——“Layer limit”: Maximum pile up layers of the same
111
Symbol
package.
——“Humidity limit”: Humidity limit for transportation and

storage environment.
——“Temperature limit”: Temperature limit for transportation

and storage environment.
Note: The illustrations are for reference only, subject to pictures on the
outer package.
112
Specification
Appendix 2 Specification
A 2.1 Reagent
Diluent, lyse and probe cleanser
A 2.2 Parameter Information
Item Unit
WBC 109/L
Neu# 109/L
Lym# 109/L
Mid# 109/L
Neu% %
Lym% %
Mid% %
RBC 1012/L
HGB g/L
HCT %
113
Specification
Item Unit
MCV fL
MCH pg
MCHC g/L
RDW-SD fL
RDW-CV %
PLT 109/L
MPV fL
PDW None
PCT %
P-LCR %
RBC Histogram None
PLT Histogram None
WBC Histogram None
2-1 Parameter Information
114
Specification
A 2.3 Sampling Characteristics
Test Mode Sample Volume
Venous 10μL
Capillary 10μL
Prediluted 20μL
2-2 Sampling Characteristics
A 2.4 Performance Index
Item Range
WBC 0~200.0×109/L
RBC 0~20.00×1012/L
HGB 0~300g/L
115
Specification
Item Range
PLT 0~2000×109/L
HCT 0%~80%
2-3 Performance Index
A 2.5 Background Range
Item Range
WBC ≤ 0.2×109/L
RBC ≤ 0.02×1012/L
HGB ≤ 1.0g/L
HCT ≤ 0.5%
PLT ≤ 10.0×109/L
2-4 Background Range
116
Specification
A 2.6 Linear Range

Item Range SD
0~5.9×109/L (±0.3×109)/L
WBC
6.0~99.9×109/L ±5%
0~0.99×1012/L (±0.05×1012)/L
RBC
1.0~9.99×1012/L ±5%
0~99g/L ±2.0g/L
HGB
100~300g/L ±2%
0~99×109/L (±8.0×109)/L
PLT
100~999×109/L ±10%
2-5 Linear Range
A 2.7 Repeatability Index

Test the sample for 11 times, and use the results from the second to
eleventh test to get repeatability statistics.
Item CV Range
WBC ≤2.0% (4.0~15.0×109)/L
RBC ≤1.9% (3.5~6.0×1012)/L
HGB ≤1.9% (110.0~180.0)g/L
MCV ≤0.4% (80.0~110.0)fL

PLT ≤4.0% (100.0~500.0×109)/L
117
Specification
Item CV Range
LYM%≥15.0%,
LYM% ≤8.0%
WBC≥4.0×109/L
MID%≥5.0%,
MID% ≤15.0%
WBC≥4.0×109/L
NEUT%≥30.0%,
NEUT% ≤8.0%
WBC≥4.0×109/L
2-6 Repeatability Index
A 2.8 Pollution Rate

Item Result
WBC ≤2%
RBC ≤1%
HGB ≤2%
PLT ≤2%
2-7 Pollution Rate
A.2.9 Accuracy
Deviation
Parameter Range
Requirement
WBC 3.5×109/L～9.5×109/L ≤±10%
118
Specification
RBC 3.8×1012/L ~ 5.8×1012/L ≤±6%
HGB 115g/L ~ 175g/L ≤±6%

82fL～100fL（MCV）or
MCV ≤±7%
35% ~ 50%（HCT）
PLT 125 ×109/L ~350×109/L ≤±15%
2-8 Accuracy
A 2.10 Input / Output

Touch Pen (Optional)
Mouse
Printer (Optional)
R232 Port
VGA Port
Power Supply:
Voltage Frequency
Main Unit 100-240V～ 50/60Hz
119
P0 1 . 9 1 . 3 0 0 2 5 4 - 0 4

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Auto Hematology Analyzer

Release Date: March 9, 2020

Item No.: P01.91.300254-04

The manufacturer owns the copyrights of this manual. Without prior

Materials protected by the copyright law, including but not limited to

The manufacturer reserves the final explanation right to this manual.

This system can only be operated by test professionals, doctors, lab

It is important for the hospital or organization that employs this

Avoidance from potential hazard

Warning: The instrument must be operated as the operating

Caution: Emphasize the operating methods that must be obeyed.

Notice: To emphasize important information. All personnel that may

To operate the instrument safely and effectively, be sure to read the

Avoid electric shock

1) When the power is on, the unauthorized maintenance personnel

Defense for biohazard and chemical hazards

Improper use of the sample may result in being infected.

If the skin touched the sample, manage it according to operator

Be sure not to use flammable dangerous materials around the

Prevention of fire and explosion

To operate the instrument safely and reliably, be sure to obey the

Pay attention to the application range of the instrument. Make sure

Limitation of operating environment

The instrument should be installed according to the required

Only personnel trained and authorized by the manufacturer can

Maintenance and service

Be sure to service and maintain the instrument according to this

Table of Contents ................................................................................. i

Chapter 1 Instrument Introduction ................................................... 1

1.1 Composition ................................................................................ 1

1.1.1 Host ...................................................................................... 1

1.1.2 Accessory ............................................................................. 1

1.2 Purpose ....................................................................................... 2

1.3 Specifications .............................................................................. 4

1.4 Structure .................................................................................... 11

1.4.1 Front Panel ......................................................................... 11

1.4.2 Rear Panel ......................................................................... 12

1.5 Operation .................................................................................. 13

1.5.1 Display Screen ................................................................... 13

1.5.3 Version Information ............................................................ 18

1.6 Detection Principle .................................................................... 19

1.6.1 Detection Principles of WBC, RBC and PLT ...................... 19

1.6.2 Detection Principle of HGB ................................................ 21

1.6.3 Volume Distribution of Blood Cell ....................................... 21

1.6.4 Results and Calculation of Parameter Measurement ........ 22

Chapter 2 Installation ....................................................................... 25

2.1 Package .................................................................................... 25

2.2 Unpack ...................................................................................... 25

2.3 Installation Requirements .......................................................... 26

2.4 Reagent Tubing Connection ..................................................... 28

2.4.1 Lyse Connection ................................................................. 28

2.4.2 Diluent Connection ............................................................. 28

2.4.3 Waste Connection .............................................................. 28

2.5 Recorder Paper Installation....................................................... 30

2.6 Keyboard and Mouse Installation .............................................. 30

2.7 Printer Installation (Optional) .................................................... 31

2.8 Power Cable Connection .......................................................... 31

Chapter 3 Sample Analysis.............................................................. 32

3.1 Preparation before Startup ........................................................ 32

3.2 Startup ....................................................................................... 32

3.2.1 Function .............................................................................. 34

3.3 Background Test ....................................................................... 36

3.4 Quality Control .......................................................................... 39

3.5 Preparation for Sample Collection ............................................ 39